NCT04237168

Brief Summary

This study will evaluate IgNGS at different time points in newly diagnosed DLBCL patients homogeneously treated (RCHOP) to address its correlation with conventional techniques (i.e., positron emission tomography/computed tomography imaging (PET/CT) and outcome.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

January 29, 2020

Status Verified

January 1, 2020

Enrollment Period

1.9 years

First QC Date

January 17, 2020

Last Update Submit

January 27, 2020

Conditions

Lymphoma, Large B-Cell, Diffuse

Keywords

Diffuse large B cell lymphomaimmunoglobulin gene next generation sequencingliquid biopsy

Outcome Measures

Primary Outcomes (1)

  • Association between ctDNA level and clinical response at the end of treatment

    Correlation between ctDNA level (in nanograms) and clinical response per PET/CT at the end of treatment (responses will be defined according to International Working Group consensus response evaluation criteria in lymphoma - IWGRECIL - 2017) will be assessed by means of Spearman correlation.

    12-18 months

Secondary Outcomes (2)

  • Correlation between detection of tumor clonotype ctDNA and relapse

    18 months

  • Impact of IgNGS at the end of treatment and 6 months after treatment on outcome (as measured by progression-free survival PFS)

    18 months

Other Outcomes (2)

  • Clinical impact of the described technique for minimal residual disease (MRD) detection in patients with DLBCL

    3 years

  • Feasibility of the described technique

    3 years

Study Arms (1)

DLBCL patients

newly diagnosed DLBCL (de novo, all ages) patients treated with RCHOP (first-line treatment regimen)

Diagnostic Test: IgNGS from circulating tumor DNA

Interventions

IgNGS from circulating tumor DNADIAGNOSTIC_TEST

3 longitudinal plasma samples will be evaluated at three different time points per patient: 0 (pre-treatment), end of treatment, and at 6 months after treatment.

DLBCL patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

newly DLBCL patients (diagnosed and treated in "Hospital de la Santa Creu i Sant Pau")

You may not qualify if:

  • Primary mediastinal DLBCL.
  • Transformed DLBCL
  • Patients HIV+
  • Central Nervous System (CNS) DLBCL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Related Publications (5)

  • Herrera AF, Armand P. Minimal Residual Disease Assessment in Lymphoma: Methods and Applications. J Clin Oncol. 2017 Dec 1;35(34):3877-3887. doi: 10.1200/JCO.2017.74.5281. Epub 2017 Sep 21.

    PMID: 28933999BACKGROUND

  • Scherer F, Kurtz DM, Newman AM, Stehr H, Craig AF, Esfahani MS, Lovejoy AF, Chabon JJ, Klass DM, Liu CL, Zhou L, Glover C, Visser BC, Poultsides GA, Advani RH, Maeda LS, Gupta NK, Levy R, Ohgami RS, Kunder CA, Diehn M, Alizadeh AA. Distinct biological subtypes and patterns of genome evolution in lymphoma revealed by circulating tumor DNA. Sci Transl Med. 2016 Nov 9;8(364):364ra155. doi: 10.1126/scitranslmed.aai8545.

    PMID: 27831904BACKGROUND

  • Scherer F, Kurtz DM, Diehn M, Alizadeh AA. High-throughput sequencing for noninvasive disease detection in hematologic malignancies. Blood. 2017 Jul 27;130(4):440-452. doi: 10.1182/blood-2017-03-735639. Epub 2017 Jun 9.

    PMID: 28600337BACKGROUND

  • Kurtz DM, Green MR, Bratman SV, Scherer F, Liu CL, Kunder CA, Takahashi K, Glover C, Keane C, Kihira S, Visser B, Callahan J, Kong KA, Faham M, Corbelli KS, Miklos D, Advani RH, Levy R, Hicks RJ, Hertzberg M, Ohgami RS, Gandhi MK, Diehn M, Alizadeh AA. Noninvasive monitoring of diffuse large B-cell lymphoma by immunoglobulin high-throughput sequencing. Blood. 2015 Jun 11;125(24):3679-87. doi: 10.1182/blood-2015-03-635169. Epub 2015 Apr 17.

    PMID: 25887775BACKGROUND

  • Roschewski M, Dunleavy K, Pittaluga S, Moorhead M, Pepin F, Kong K, Shovlin M, Jaffe ES, Staudt LM, Lai C, Steinberg SM, Chen CC, Zheng J, Willis TD, Faham M, Wilson WH. Circulating tumour DNA and CT monitoring in patients with untreated diffuse large B-cell lymphoma: a correlative biomarker study. Lancet Oncol. 2015 May;16(5):541-9. doi: 10.1016/S1470-2045(15)70106-3. Epub 2015 Apr 1.

    PMID: 25842160BACKGROUND

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Javier Briones

    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Javier Briones, PhD

CONTACT

+34935565649jbriones@santpau.cat

Anna Monter-Rovira, MD

CONTACT

amonter@santpau.cat

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2020

First Posted

January 23, 2020

Study Start

January 1, 2020

Primary Completion

December 1, 2021

Study Completion

July 1, 2022

Last Updated

January 29, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

relevant results will be published in scientific journals available to all researchers.

Locations

ES(1)